Energizable ophthalmic lens device with a programmaable media insert

ABSTRACT

The present invention discloses an Ophthalmic Lens device with a programmable Media Insert. In some embodiments, a Media Insert may be programmable to allow for further customization of the energized Ophthalmic Lens. The programming may occur after the electrical components have been encapsulated in the programmable Media Insert. In some embodiments, the Media Insert may be programmed prior to or during the manufacturing process. Alternatively, the Media Insert may be programmable after manufacturing process, such as, for example, through use of a wireless programming apparatus or device. In some such embodiments, the programming device may comprise an overlay, wherein the overlay may program the Media Insert when placed in proximity to the Media Insert.

FIELD OF USE

This invention describes methods, apparatus, and devices related toprogramming an energizable Ophthalmic Lens with a programmable MediaInsert. More specifically, this invention describes an energizableOphthalmic Lens device with a programmable Media Insert. In someaspects, the Media Insert may be wirelessly programmed after theelectrical components have been encapsulated in the programmable MediaInsert or after the Media Insert has been assembled with OphthalmicLens.

BACKGROUND

Traditionally, an Ophthalmic Device, such as a contact lens, anintraocular lens, or a punctal plug included a biocompatible device witha corrective, cosmetic, or therapeutic quality. A contact lens, forexample, can provide one or more of vision correcting functionality,cosmetic enhancement, and therapeutic effects. Each function is providedby a physical characteristic of the lens. A design incorporating arefractive quality into a lens can provide a vision corrective function.A pigment incorporated into the lens can provide a cosmetic enhancement.An active agent incorporated into a lens can provide a therapeuticfunctionality. Such physical characteristics may be accomplished withoutthe lens entering into an energized state.

More recently, active components have been included in a contact Lens,and the inclusion may involve the incorporation of energizing elementswithin the Ophthalmic Device. The relatively complicated components toaccomplish this effect may derive improved characteristics by includingthem in insert devices which are then included with standard or similarmaterials useful in the fabrication of state of the art OphthalmicLenses.

The inclusion of active components in an Ophthalmic Lens broadens thepotential functionalities of the Ophthalmic Lens. With an increasedrange of functionalities, customization may become more significant butalso more complex. Accordingly, new means of personalizing energizableOphthalmic Lens may be necessary.

It may be desirable to improve the process, methods, and resultingdevices for realizing event coloration mechanisms of various kinds. Itmay be anticipated that some of the solutions for event colorationmechanisms in energizable Ophthalmic Lenses may provide novel aspectsfor non-energized devices and other biomedical devices. Accordinglynovel methods, devices, and apparatus relating to programming andmanufacturing an energized Ophthalmic Lens with a programmable MediaInsert are therefore important.

SUMMARY

Accordingly, the present invention includes innovations relating to anOphthalmic Lens comprising a programmable Media Insert capable ofproviding a first functionality to the Ophthalmic Lens, wherein a set ofprogramming parameters is capable of customizing the firstfunctionality; and a soft lens base, wherein the soft lens base is incontact with at least a portion of the programmable Media Insert. Insome embodiments, the soft lens base is capable of providing a secondfunctionality, for example, static vision correction.

In some such embodiments, the programmable Media Insert may comprise apower source; a first processor in electrical communication with thepower source, wherein the processor comprises a first executablesoftware, wherein the first executable software is capable ofcontrolling the energizable element based on the set of programmingparameters; conductive traces capable of allowing electricalcommunication between the processor and the power source; and anenergizable element in electrical communication with the first processorand the power source, wherein the energizable element is capable ofproviding the first functionality to the Ophthalmic Lens.

In some embodiments, the Media Insert may further comprise a firstreceiver capable of wirelessly receiving the set of programmingparameters, wherein the first receiver may be in electricalcommunication with the first processor. In some such embodiments,programmable Media Insert may further comprises a monitoring portion inelectrical communication with the first processor, wherein themonitoring portion is capable of collecting the predefined data whilethe Ophthalmic Lens is located on the eye, and wherein the firstprocessor is capable of storing the predefined data. The Media Insertmay comprise a second transmitter, wherein the second transmitter iscapable of wirelessly transmitting the predefined data to a deviceexternal to the Ophthalmic Lens.

In some embodiments, the Ophthalmic Lens may further comprise aprogramming overlay capable of programming the programmable MediaInsert, wherein the programming overlay may be capable of securelyfitting over one or both the soft lens base and programmable MediaInsert. The programming overlay may be placed over the soft lens baseand programmable Media Insert prior to placement on the eye.Alternatively, the assembly may occur on the eye.

A stock-keeping unit code may be capable of associating the set ofprogramming parameters with the Ophthalmic Lens. In some embodiments,the stock-keeping unit code may be incorporated on the surface of one ormore of the programmable Media Insert, the soft lens base, or theprogramming overlay.

In some embodiments, the programming overlay may comprise a secondreceiver capable of wirelessly receiving programming parameter data; afirst transmitter capable of wirelessly transmitting the set ofprogramming parameters to the programmable Media Insert when the firsttransmitter is in proximity to the programmable Media Insert; and asecond processor in logical communication with the receiver and thetransmitter, wherein the processor is capable of storing the set ofprogramming parameter.

The programmable Media Insert may further comprise a monitoring portionin electrical communication with the first processor, wherein themonitoring portion may be capable of collecting predefined data whilethe Ophthalmic Lens is located on an eye, and wherein the firstprocessor is capable of storing the predefined data. In some suchembodiments, Media Insert may comprise a second transmitter, wherein thesecond transmitter is capable of wirelessly transmitting the predefineddata to a third receiver.

The programming overlay may further comprise the third receiver, whereinthe third receiver is in logical communication with the secondprocessor. The second processor may comprise a second executablesoftware, wherein the second executable software may be capable ofadjusting the set of programming parameters based on the predefineddata. The first transmitter may be capable of wirelessly transmittingthe adjusted set of programming parameters to the programmable MediaInsert.

In some embodiments, the programming overlay may further comprises afirst alignment feature, and the programmable Media Insert may comprisesa second alignment feature, wherein the first alignment feature may becapable of aligning with the second alignment feature. In some suchaspects, the aligning comprises a magnetic attraction between the firstalignment feature and the second alignment feature. The aligning may becapable of orienting the first transmitter in proximity to the firstreceiver. The aligning may be capable of securing the programmingoverlay to one or both the soft lens base and the programmable MediaInsert.

DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an exemplary embodiment of a Media Insert for anenergized Ophthalmic Lens and an exemplary embodiment of an energizedOphthalmic Lens.

FIG. 2A illustrates a top down view of an exemplary embodiment of anunprogrammed energizable Ophthalmic Lens and a programming overlay.

FIG. 2B illustrates a cross sectional view of an exemplary embodiment ofan unprogrammed energizable Ophthalmic Lens and a programming overlay.

FIG. 3 illustrates an exemplary process flowchart for preprogramming anenergizable Ophthalmic Lens.

FIG. 4 illustrates an exemplary apparatus for programming an energizableOphthalmic Lens.

FIG. 5 illustrates an alternative process flowchart for programming anenergizable Ophthalmic Lens.

FIG. 6 illustrates an alternative process flowchart for programming anenergizable Ophthalmic Lens.

DETAILED DESCRIPTION OF THE INVENTION

The present invention describes an energizable Ophthalmic Lens devicewith a programmable Media Insert. In general, according to someembodiments of the present invention, a programmable Media Insert may beincorporated with an energizable Ophthalmic Lens, and the Media Insertmay be wirelessly programmed.

In the following sections, detailed descriptions of embodiments of theinvention will be given. The description of both preferred andalternative embodiments are exemplary embodiments only, and it isunderstood that to those skilled in the art that variations,modifications, and alterations may be apparent. It is therefore to beunderstood that said exemplary embodiments do not limit the scope of theunderlying invention.

GLOSSARY

In this description and claims directed to the presented invention,various terms may be used for which the following definitions willapply:

Adhesion Promoter: as used herein refers to a material or process thatincreases the adhesiveness of the Rigid Insert to an encapsulant.

Back Curve Piece or Back Insert Piece: as used herein refers to a solidelement of a Multi-Piece Insert that, when assembled into the saidinsert, will occupy a location on the side of the Ophthalmic Lens thatis on the back. In an ophthalmic device, such a piece would be locatedon the side of the insert that would be closer to the wearer's eyesurface. In some embodiments, the Back Curve Piece may contain andinclude a region in the center of an ophthalmic device through whichlight may proceed into the wearer's eye. This region may be called anOptical Zone. In other embodiments, the piece may take an annular shapewhere it does not contain or include some or all of the regions in anOptical Zone. In some embodiments of an ophthalmic insert, there may bemultiple Back Curve Pieces, and one of them may include the OpticalZone, while others may be annular or portions of an annulus.

Component: as used herein refers to a device capable of drawingelectrical current from an Energy Source to perform one or more of achange of logical state or physical state.

Deposit: as used herein refers to any application of material,including, for example, a coating or a film.

Disinfecting Radiation: as used herein refers to a frequency andintensity of radiation sufficient to kill unwanted life forms byreceiving a Disinfecting Radiation Dose.

Disinfecting Radiation Dose: as used herein refers to an amount ofradiation to reduce an amount of life forms by at least two logs on alogarithmic scale and preferably three logs or more, wherein life formsinclude at least bacteria, viruses, molds, and fungi.

Electrical Communication: as used herein refers to being influenced byan electrical field. In the case of conductive materials, the influencemay result from or in the flow of electrical current. In othermaterials, it may be an electrical potential field that causes aninfluence, such as the tendency to orient permanent and inducedmolecular dipoles along field lines as an example.

Encapsulate: as used herein refers to creating a barrier to separate anentity, such as, for example, a Media Insert, from an environmentadjacent to the entity.

Encapsulant: as used herein refers to a layer formed surrounding anentity, such as, for example, a Media Insert, that creates a barrier toseparate the entity from an environment adjacent to the entity. Forexample, Encapsulants may be comprised of silicone hydrogels, such asEtafilcon, Galyfilcon, Narafilcon, and Senofilcon, or other hydrogelcontact lens material. In some embodiments, an Encapsulant may besemipermeable to contain specified substances within the entity andpreventing specified substances, such as, for example, water, fromentering the entity.

Energized: as used herein refers to the state of being able to supplyelectrical current to or to have electrical Energy stored within.

Energy: as used herein refers to the capacity of a physical system to dowork. Many uses within this invention may relate to the said capacity ofbeing able to perform electrical actions in doing work.

Energy Harvesters: as used herein refers to devices capable ofextracting Energy from the environment and converting it to electricalEnergy.

Energy Source: as used herein refers to any device or layer that iscapable of supplying Energy or placing a logical or electrical device inan Energized state.

Event: as used herein refers to a defined set of parameters, such as,for example, a biomarker level, energization level, pH level, or avisual recognition of a particular object. An event may be specific to awearer, such as a level of medication, or may be generally applicable toall wearers, such as temperature.

Front Curve Piece or Front Insert Piece: as used herein refers to asolid element of a multi-piece Rigid Insert or Media Insert that, whenassembled into the said insert, will occupy a location on the side ofthe Ophthalmic Lens that is on the front. In an ophthalmic device, sucha piece would be located on the side of the insert that would be furtherfrom the wearer's eye surface. In some embodiments, the piece maycontain and include a region in the center of an ophthalmic devicethrough which light may proceed into the wearer's eye. This region maybe called an Optical Zone. In other embodiments, the piece may take anannular shape where it does not contain or include some or all of theregions in an Optical Zone. In some embodiments of an ophthalmic insert,there may be multiple Front Curve Pieces, and one of them may includethe Optical Zone, while others may be annular or portions of an annulus.

Functionalized: as used herein refers to making a layer or device ableto perform a function including for example, energization, activation,or control.

Insert Piece: as used herein refers to a solid element of a multi-pieceRigid Insert or Media Insert that may be assembled into the Rigid Insertor Media Insert. In an Ophthalmic Device, an Insert Piece may containand include a region in the center of an Ophthalmic Device through whichlight may proceed into the user's eye. This region may be called anOptic Zone. In other embodiments, the piece may take an annular shapewhere it does not contain or include some or all of the regions in anOptical Zone. In some embodiments, a Rigid Insert or Media Insert maycomprise multiple Inserts Pieces, wherein some Insert Pieces may includethe Optic Zone and other Insert Pieces may be annular or portions of anannulus.

Ophthalmic Lens or Ophthalmic Device or Lens: as used herein refers toany device that resides in or on the eye, in contrast to an eyeglasslens. The device may provide optical correction, may be cosmetic, orprovide some functionality unrelated to optic quality. For example, theterm Lens may refer to a contact Lens, intraocular Lens, overlay Lens,ocular insert, optical insert, or other similar device through whichvision is corrected or modified, or through which eye physiology iscosmetically enhanced (e.g. iris color) without impeding vision.Alternatively, Lens may refer to a device that may be placed on the eyewith a function other than vision correction, such as, for example,monitoring of a constituent of tear fluid or means of administering anactive agent. In some embodiments, the preferred Lenses of the inventionmay be soft contact Lenses that are made from silicone elastomers orhydrogels, which may include, for example, silicone hydrogels andfluorohydrogels.

Lens-forming Mixture or Reactive Mixture or RMM: as used herein refer toa monomeric composition and/or prepolymer material that may be cured andcross-linked or cross-linked to form an ophthalmic Lens. Variousembodiments may include Lens-forming mixtures with one or more additivessuch as UV blockers, tints, diluents, photoinitiators or catalysts, andother additives that may be useful in an ophthalmic Lenses such as,contact or intraocular Lenses.

Lens-Forming Surface: as used herein refers to a surface that can beused to mold a Lens. In some embodiments, any such surface can have anoptical quality surface finish, which indicates that it is sufficientlysmooth and formed so that a Lens surface fashioned by the polymerizationof a Lens forming material in contact with the molding surface isoptically acceptable. Further, in some embodiments, the Lens-formingSurface may have a geometry that may be necessary to impart to the Lenssurface the desired optical characteristics, including, for example,spherical, aspherical and cylinder Power, wave front aberrationcorrection, and corneal topography correction.

Liquid Crystal: as used herein refers to a state of matter havingproperties between a conventional liquid and a solid crystal. A LiquidCrystal cannot be characterized as a solid but its molecules exhibitsome degree of alignment. As used herein, a Liquid Crystal is notlimited to a particular phase or structure, but a Liquid Crystal mayhave a specific Resting Orientation. The orientation and phases of aLiquid Crystal may be manipulated by external forces such as, forexample, temperature, magnetism, or electricity, depending on the classof Liquid Crystal.

Media Insert: as used herein refers to an encapsulated insert that willbe included in an energized ophthalmic device. The energization elementsand circuitry may be embedded in the Media Insert. The Media Insertdefines the primary purpose of the energized ophthalmic device. Forexample, in embodiments where the energized ophthalmic device allows theuser to adjust the optic power, the Media Insert may includeenergization elements that control a liquid meniscus portion in theOptical Zone. Alternatively, a Media Insert may be annular so that theOptical Zone is void of material. In such embodiments, the energizedfunction of the Lens may not be optic quality but may be, for example,monitoring glucose or administering medicine.

Mold: as used herein refers to a rigid or semi-rigid object that may beused to form Lenses from uncured formulations. Some preferred Moldsinclude two Mold parts forming a front curve Mold part and a back curveMold part, each Mold part having at least one acceptable Lens-FormingSurface.

Optic Zone: as used herein refers to an area of an ophthalmic Lensthrough which a user of the ophthalmic Lens sees.

Precure: as used herein refers to a process that partially cures amixture. In some embodiments, a precuring process may comprise ashortened period of the full curing process. Alternatively, theprecuring process may comprise a unique process, for example, byexposing the mixture to different temperatures and wavelengths of lightthan may be used to fully cure the material.

Predose: as used herein refers to the initial deposition of material ina quantity that is less than the full amount that may be necessary forthe completion of the process. For example, a predose may include aquarter of the necessary substance.

Postdose: as used herein refers to a deposition of material in theremaining quantity after the predose that may be necessary for thecompletion of the process. For example, where the predose includes aquarter of the necessary substance, a subsequent postdose may providethe remaining three quarters of the substance.

Power: as used herein refers to work done or Energy transferred per unitof time.

Rechargeable or Re-energizable: as used herein refers to a capability ofbeing restored to a state with higher capacity to do work. Many useswithin this invention may relate to the capability of being restoredwith the ability to flow electrical current at a certain rate forcertain, reestablished time periods.

Reenergize or Recharge: as used herein refers to restoring to a statewith higher capacity to do work. Many uses within this invention mayrelate to restoring a device to the capability to flow electricalcurrent at a certain rate for certain, reestablished time periods.

Released or Released from a Mold: as used herein refers to a Lens thatis either completely separated from the Mold or is only loosely attachedso that it may be removed with mild agitation or pushed off with a swab.

Storage Mode: as used herein refers to a state of a system comprisingelectronic components where a power source is supplying or is requiredto supply a minimal designed load current. This term is notinterchangeable with Standby Mode.

Three-dimensional Surface or Three-dimensional Substrate: as used hereinrefers to any surface or substrate that has been three-dimensionallyformed where the topography is designed for a specific purpose, incontrast to a planar surface.

Trace: as used herein refers to a battery component capable ofelectrically connecting the circuit components. For example, circuitTraces may include copper or gold when the substrate is a printedcircuit board and may be copper, gold, or printed Deposit in a flexcircuit. Traces may also be comprised of nonmetallic materials,chemicals, or mixtures thereof.

Variable Optic: as used herein refers to the capacity to change anoptical quality, such as, for example, the optical power of a lens orthe polarizing angle.

Ophthalmic Lens

Proceeding to FIG. 1, an exemplary embodiment of a Media Insert 100 foran energized Ophthalmic Device and a corresponding energized OphthalmicDevice 150 are illustrated. The Media Insert 100 may comprise an OpticalZone 120 that may or may not be functional to provide vision correction.Where the energized function of the Ophthalmic Device is unrelated tovision, the Optical Zone 120 of the Media Insert 100 may be void ofmaterial. In some embodiments, the Media Insert 100 may include aportion not in the Optical Zone 120 comprising a substrate 115incorporated with energization elements 110 and electronic components105.

In some embodiments, a power source 110, which may be, for example, abattery, and a load 105, which may be, for example, a semiconductor die,may be attached to the substrate 115. Conductive traces 125 and 130 mayelectrically interconnect the electronic components 105 and theenergization elements 110.

In some embodiments, the electronic components 105 may include aprocessor, which may be programmed to establish the parameters of thefunctionality of the Ophthalmic Lens. For example, where the OphthalmicLens comprises a variable optic portion in the Optical Zone 120, theprocessor may be programmed to set the energized optical power. Such anembodiment may allow for mass production of Media Inserts that have thesame composition but include uniquely programmed processors.

The processor may be programmed before the encapsulation of theelectrical components 105, 130, 110, 125 within the Media Insert.Alternatively, the processor may be programmed wirelessly afterencapsulation. Wireless programming may allow for customization afterthe manufacturing process, for example, through a programming apparatus,which may be portable. For illustrative purposes, the Media Inserts 100are shown to include a portion in the Optical Zone 120. However, wherethe functionality of the Media Insert may not be related to vision, theMedia Insert may be annular, wherein the components of the Media Insertare outside of the Optical Zone.

The Media Insert 100 may be fully encapsulated to protect and containthe energization elements 110, traces 125 and 130, and electroniccomponents 105. In some embodiments, the encapsulating material may besemi-permeable, for example, to prevent specific substances, such aswater, from entering the Media Insert 100 and to allow specificsubstances, such as ambient gasses or the byproducts of reactions withinenergization elements, to penetrate or escape from the Media Insert 100.

In some embodiments, the Media Insert 100 may be included in anOphthalmic Device 150, which may comprise a polymeric biocompatiblematerial. The Ophthalmic Device 150 may include a rigid center, softskirt design wherein a central rigid optical element comprises the MediaInsert 100. In some specific embodiments, the Media Insert 100 may be indirect contact with the atmosphere and the corneal surface on respectiveanterior and posterior surfaces, or alternatively, the Media Insert 100may be encapsulated in the Ophthalmic Device 150. The periphery 155 ofthe Ophthalmic Device 150 may be a soft skirt material, including, forexample, a polymerized Reactive Monomer Mixture, such as a hydrogelmaterial.

Proceeding to FIG. 2A, an exemplary unprogrammed energizable OphthalmicLens base 200 and a programming overlay 210 are illustrated in a topdown view. In some embodiments, an unprogrammed energizable OphthalmicLens base 200 may include a soft lens portion 201 and a Media Insert202, such as, for example, described in FIG. 1. The Media Insert 202 maycomprise the materials for the defined functionality. For example, wherethe Media Insert 202 provides a variable optic functionality, the MediaInsert 202 may include a liquid lens or liquid crystal portion 205 inthe Optic Zone of the Ophthalmic Lens base 200. Alternatively, the MediaInsert 202 may monitor specific constituents in the tear fluid, and theMedia Insert 202 may include specific reactants or binding chemicals toquantify the concentration of those constituents.

Prior to programming, the processor 203 of the Media Insert 202 mayinclude the executable software that may allow for functional control,but may not be programmed to the specified parameters for a particularuser. For example, where the Media Insert 202 provides a variable opticfunctionality, the processor 203 may include the executable softwarenecessary to operate the energization of the liquid lens portion 205,but the processor may not be programmed to the varied optic powers.

In its unprogrammed state, the Ophthalmic Lens base 200 may provide anonenergized functionality, such as, for example, a staticvision-correcting power. Such an embodiment may also allow for safe andfunctional default mode, if, for example, the programming orenergization fails. Where a secondary functionality may not benecessary, a malfunctioning Media Insert 202 may default to an opticallytransparent state, wherein the user's vision may not be impaired.

A programming overlay 210 may comprise a thin biocompatible portion 211,in similar shape, size, and composition to the soft portion 201 of theOphthalmic Lens base 200. The programming overlay 210 may be capable ofprogramming the Media Insert 202 when placed in proximity to theOphthalmic Lens base 200. For example, the Ophthalmic Lens base 200 maybe placed on the eye, and the user may place the programming overlay 210on top of the Ophthalmic Lens base 200. Once in proximity to the MediaInsert 202, the programming overlay 210 may transmit the programmingdata to the processor 203 in the Media Insert 202.

In some embodiments, the Media Insert 202 may be fully encapsulated,wherein the encapsulation protects and isolates the components of theMedia Insert 202 from the ocular environment, limiting direct contactbetween the ocular environment and the components, including, forexample, electrical components. Accordingly, the programming overlay 210may be capable of wirelessly communicating with the Media Insert 202. Insome embodiments, the Media Insert 202 may further comprise a sensor 204capable of sensing the proximity of the programming overlay 210 andreceiving programming data. Similarly, the programming overlay 210 mayfurther comprise a transmitting sensor 214 capable of sensing theproximity of the Media Insert 202 and transmitting the programming data.

The Media Insert 202 sensor 204 may be in logical communication with theprocessor 203, and the programming overlay 210 sensor 214 may be inlogical communication with the overlay processor 213. When theprogramming overlay 210 is placed over the Ophthalmic Lens base 200, aprogrammed Ophthalmic Lens 220 may be formed.

In some embodiments, such as illustrated, the sensors 204, 214 may bedirectly aligned. The small size of the sensors 204, 214 may make itdifficult to align. Accordingly, alignment features may facilitate theorientation between the programming overlay 210, the Media Insert 202and sensor 204. In some embodiments, the alignment features may bemagnetic, wherein the programming overlay 210 may self-align when placedin proximity to the complementary alignment feature on one or both theOphthalmic Lens base 200 or the programmable Media Insert 202.

In other embodiments, the sensors may be less sensitive and directalignment may not be required. In such embodiments, alignment may stillbe significant. For example, an alignment feature 212 may secure the fitbetween the programming overlay 210 and one or both the Ophthalmic Lensbase 200 or the programmable Media Insert 202. The secured positioningmay allow for a consistently comfortable fit, and the security may limitmovement between the programming overlay 210, Ophthalmic Lens base 200,and the programmable Media Insert 202.

The programming overlay 210 may also include a processor 213, which maybe able to store the programmed parameters. The processor 213 may alsoinclude executable software capable of controlling the reception andtransfer of data, including, for example, the programming parameters. Insome embodiments, the executable software in the programming overlay 210may translate the input programming parameters to an operational code.In other embodiments, the programming overlay 210 may only transmit theprogramming parameters, and executable software in the Media Insert 202processor 203 may translate the programming parameters.

Proceeding to FIG. 2B, an exemplary unprogrammed energizable OphthalmicLens base 250 and a programming overlay 260 are illustrated in crosssection. In some embodiments, the Media Insert 252 may not be fullyencapsulated by the soft lens portion 251, which may allow a closerproximity between the Media Insert 252 and the programming overlay 260.In such embodiments, the programming overlay 260 may be formed toinclude a pocket 266 for the portion of the Media Insert 252 notencapsulated by the soft lens portion 251.

In some such embodiments, the Ophthalmic Lens base 250 may include thebase prescription, such as would be included in a non-energizableOphthalmic Lens, and the programmed overlay 260 may be universal. Auniversal overlay 260 may allow the programmer, such as, for example,the ophthalmologist, to keep a stock of the overlays without committingto specific Ophthalmic Lens base 250, where the demand may be lesspredictable.

For example, where the programmed Ophthalmic Lens 250 provides variableoptic powers for patients with presbyopia, the number of patients withpresbyopia may be more predictable than the specific prescription supplydemands. The Ophthalmic Lens bases 250 may be ordered based on generaldemand or the specific demands of an individual patient, but theophthalmologist may be able to program the overlays before the patientleaves the office.

Secondary alignment features may be necessary in some embodiments, whichmay allow for a secure complete assembly 270. For example, the sensors254, 264 may be magnetic. Alternatively, the programmed overlay 260 maymechanically fit with the Ophthalmic Lens base 250, such as throughtongue and groove, or a snap fit. In some such embodiments, the fittingmechanisms may not be near the sensors, which may allow for a broaderrange of alignment mechanisms.

In still further embodiments, the sensors 254,264 may not requireparticular circular alignment. For example, the sensors 254, 264 may besensitive enough to recognize proximity when assembled 270, when theprogrammed overlay 260 may be placed on the Ophthalmic Lens base 250.

Proceeding to FIG. 3, an exemplary embodiment of a process flowchart forprocessing and preprogramming an energizable Ophthalmic Lens 342 isillustrated. In some embodiments, the programming may occur at 320 priorto including the Media Insert 321 in the Ophthalmic Lens 331, at 340. Insome such embodiments, the manufacturer may also be the programmer.Alternatively, the processor may be preprogrammed, wherein theprogramming at 320 may occur separately from the assembly steps, at 330,340, and the packaging steps, at 350, 360.

As an illustrative example, a doctor, such as an ophthalmologist orphysician, may assess a patient to determine the necessary parametersfor the energizable Ophthalmic Lens 332. Where the functionality of theOphthalmic Lens 332 is directly related to the eye, including, forexample, vision correction or administering a pain relieving ointment toa post-operative eye, an ophthalmologist may be best suited to definethe parameters.

In other cases, such as where the Ophthalmic Lens 342 may be capable ofmonitoring or treating a specific health condition, doctors other thanan ophthalmologist may define the parameters for the Ophthalmic Lens342. For example, a Media Insert 331 may interact or interface with theocular environment, such as the tear fluid. In other embodiments, suchas where the Ophthalmic Lens provides a primarily cosmetic function, theuser may define the parameters.

At 300, the defined parameters may be input, and at 310, a stock-keepingunit (SKU) may be generated unique to those parameters. The definedparameters may be input, at 310, off the manufacturing site, such as,for example, at a doctor's office or a user's home computer.Alternatively, the manufacturer may input the defined parameters, at300, based on the instructions from a user or someone on behalf of theuser.

In some embodiments, the steps at 300 and 310 may occur almostsimultaneously, either by the same device or through use of theinternet, where a SKU is immediately generated, at 310, once the definedparameters are input, at 300. In others, the SKU may be generated, at310, once the programming and manufacturing process, at 320-360. At 320,the processor 321 may be programmed according to the defined parametersassigned to the SKU. In some embodiments, the programming, at 320, mayoccur prior to assembling the Media Insert 331, at 330. In otherembodiments, the programming, at 320, may occur as part of the assemblyprocess, at 330.

At 340, the Media Insert 331 may be included in an Ophthalmic Lens 342,such as, for example, by adding a soft skirt portion 341, encapsulatingthe Media Insert 331 in a soft, biocompatible material 341, or byfitting the Media Insert 331 into a pocket of the soft lens portion 341.Various techniques may be practical depending on method of inclusion.For example, a Media Insert 332 may be encapsulated, at 340, through aninjection mold process. Alternatively, the soft lens portion 341 may beformed independently through freeform techniques, such as throughexposure to actinic radiation, which may allow the formation of a fittedpocket.

In some embodiments at 350, the programmed Ophthalmic Lens 342 may befurther packaged for shipping. The packaging 351 may include the SKU 311number, such as through a bar code, and a label 352, which may listproperties of the programmed Ophthalmic Lens 342, including, forexample, size, resting optic power, and energized optic power. Forexemplary purposes, the packaging 351 is illustrated as a blisterembodiment. Other embodiments may be practical and should be consideredpart of the inventive art included herein. In some such embodiments, at360, the packages 351 of Ophthalmic Lenses 342 may be further includedin boxes 361, as may be common with traditional non-energized OphthalmicLenses. The boxes 361 may include similar markings as the package 351,such as the label 352 and the SKU 311.

A programming method where the programming occurs prior to theencapsulation of the Media Insert 331 may be particularly preferablewhere customization of other components of the Ophthalmic Lens 342 orMedia Insert 331 may be necessary. In some embodiments, the OphthalmicLens 342 may further include a colored iris pattern, which may obscurethe electronic components and may add a static cosmetic characteristic.The customized color may be manufactured to the specifications of aparticular SKU.

Some energizable functionality may depend on a specific substance. Forexample, monitoring glucose in the tear fluid may depend on a measurablereaction between the glucose and a reactant, such as glucose oxidase.Where the monitored conditions may be customizable, the reactants mayneed to be customized accordingly. In some such embodiments, acquiringinput parameters prior to the completed manufacturing process may bepractical.

This embodiment may also limit the need for a programming overlay, whichmay simplify the process for the user. The Ophthalmic Lens 342 may befully programmed and fully assembled when packaged at step 350.Accordingly, a further step of placing the overlay on the OphthalmicLens base may not be necessary for programming purposes.

Programming Apparatus

Proceeding to FIG. 4, an exemplary embodiment of a programming apparatus450 and a programmable Ophthalmic Lens 403 is illustrated. In someembodiments, the Ophthalmic Lens 403 may be stored before use in acontainer 400, such as, for example, a blister. The container 400 maycomprise a sealed plastic 405 with a pocket filled with an aqueoussolution to store the Ophthalmic Lens 403. Where the container 400 mayinteract with a programming apparatus 450, an alignment feature 402 maybe able to secure and orient the container 400 within the programmingapparatus 450, such as through a complementary alignment feature 452 inthe programming apparatus 450.

In some embodiments, the programming apparatus 450 may be opened similarto clam shell, wherein the container 400 may be placed in the aligningrecess 455. Alternatively, a container 400 may be inserted through aslot in the programming apparatus 450, wherein the container 400 may be“clicked” into the alignment features 452, 455.

The seal for the container 400 may comprise a material that protects theOphthalmic Lens 403 from ambient light exposure. In some embodiments,the seal may be removed prior to programming. The removal may reveal anunsealed container or may reveal a more transparent secondary seal. Inothers, where the programming device 454 within the apparatus 450 maypermeate the seal, the removal may not be necessary. It may bepreferable to preserve the sterility of the Ophthalmic Lens 403 byprogramming the Ophthalmic Lens 403 while it is still enclosed in asterile saline solution. Alternatively, the programming apparatus 450may include a sterilizing function.

In some embodiments, the container 405 may include a SKU barcode 401 ina scannable portion, for example, on the top as illustrated. Theapparatus 450 may be able to scan the SKU barcode 401 on the container405. Upon recognition, the apparatus 450 may program the Ophthalmic Lens403 based on the programming parameters associated with thestock-keeping unit. Accordingly, the SKU barcode 401 may be locatedunder a seal that may be removed prior to scanning. Alternatively, theSKU barcode 401 may be embedded in on printed on the Ophthalmic Lens403, such as on the soft lens portion 406 or the Media Insert 404.

The programmable Ophthalmic Lens 403 may comprise a Media Insert 403 anda soft lens portion 406. The Media Insert 403 may further comprise areceiver or antenna portion 407, which may allow the apparatus 450 toprogram a processor 403 within a fully encapsulated Media Insert 403. Insome embodiments, the soft lens portion 406 may further encapsulate theMedia Insert 403. Alternatively, a portion of the soft lens 406 maysecure the Media Insert 403 within the Ophthalmic Lens 403. Theprogramming apparatus 450 may comprise a scanning device 451 and aprogramming device 454.

The scanning device 451 may scan and recognize the SKU barcode 401 onthe Ophthalmic Lens 403 or its container 405. The scanning device 451may communicate electrically and logically with the programming device454, wherein the scanning device 451 may transmit the SKU data to theprogramming device 454. In some embodiments, the scanning device 451 maycomprise a light source, such as a laser, that may direct light to theSKU barcode 401, and a photodiode that may measure the intensity of thereflected light from the surface of the SKU barcode 401.

In some embodiments, the programming device 454 may comprise a databaseof the SKU numbers and their corresponding programming parameters. Insome other embodiments, the programming device 454 may be connected toan external database, such as through an internet connection or a USBconnection to a computer. In still further embodiments, a programmingapparatus 450 may be programmed directly, and the SKU barcode 401 scanmay serve as a confirmation that the unprogrammed Ophthalmic Lens 403matches the SKU assigned to the parameters.

The programming apparatus 450 may further comprise an alignment feature452 that may complement the alignment feature 402 on the container 405.Similarly, the container 405 may fit into a recess or pocket 455, whichmay help ensure the scanning device 451 and the programming device 454align with the SKU barcode 401 and the Ophthalmic Lens 403,respectively. Where the container 405 comprises a pocket, the pocket maysnap into fitted recess in the programming apparatus 450. The alignmentmay orient the container 400 within the programming apparatus 450,wherein the sensor 407 may be aligned with the programming device 454and the SKU barcode 401 may be aligned with the scanning device 451.

In some embodiments, the programming apparatus 450 may comprise aportable device. A portable size may allow a doctor to take the deviceinto examination rooms, without having to reserve space for a permanentprogramming station within the office. Alternatively, the portable sizemay allow for a personal programming apparatus 450, wherein a user mayoperate the programming apparatus 450 outside of a doctor's office, suchas, in their home.

In some embodiments, not shown, the programming apparatus may comprise ahandheld device. The handheld device may scan and program an OphthalmicLens 403 without requiring special placement or alignment. For example,a programmer may manually hold the programming apparatus in proximity tothe Ophthalmic Lens 403.

In some embodiments, an ophthalmologist or other doctor may program theprogramming apparatus 450 to recognize a left and right Ophthalmic Lens403 based on separate SKU barcodes 401, and the user may be able tooperate the apparatus 450. For example, the user may order unprogrammedOphthalmic Lenses 403 and may program the Ophthalmic Lenses 403utilizing the programming apparatus 450 as needed. For example, withdaily wear Ophthalmic Lenses 403, the user may program a left and aright Ophthalmic Lens 403 daily.

In some embodiments, the Ophthalmic Lens 403 may monitor a definedattribute, such as, for example, ambient light, serotonin in the tearfluid, or temperature of the ocular environment. To effectively treat apatient, a doctor may benefit from the data accumulated by theOphthalmic Lens 403. In some such embodiments, the programming apparatus450 may also be able to upload stored data from the Ophthalmic Lens 403associated with a particular SKU.

After use, a user may be able to place the Ophthalmic Lens 403 back intothe programming apparatus 450. In such embodiments, a SKU barcode 401may be embedded in or printed on the Ophthalmic Lens 403, for example onthe surface of the Media Insert 404 or the soft lens portion 406. Theinclusion of the SKU barcode 401 in the Ophthalmic Lens 403 instead ofor in addition to a SKU barcode 401 included on a container 400 maylimit the risk of associating the monitored data with the wrong SKU.

Where the functionality of the Ophthalmic Lens 403 includes a cosmeticaspect, the user may enter the programming parameters. For example, auser may order a set of unprogrammed cosmetic Ophthalmic Lenses 403,wherein the programming may determine the color and design of thecosmetic aspect. In some embodiments, the programming parameters may seta static design and coloration. In other embodiments, the programmingparameters may set a limited number of settings, through which the usermay cycle while the Ophthalmic Lens 403 is on eye, for example, througha blink detection mechanism.

An Ophthalmic Lens 403 may be limited to a single programming or may bereprogrammed throughout the course of the recommended use. For example,where an Ophthalmic Lens 403 includes a programmable cosmetic attribute,the user may reprogram the coloration and design scheme prior to eachuse. In some embodiments, the SKU may limit the number of times anOphthalmic Lens 403 may be programmed. Where the recommended use for anOphthalmic Lens 403 is thirty days, the Ophthalmic Lens may need to bereprogrammed daily, and may only be reprogrammed thirty times.

In some embodiments, operation times or notifications may be controlledthrough the programmed parameters, which may prompt the user to take aspecific action. For example, where monitored data may need to beuploaded periodically throughout the day, the Ophthalmic Lens 403 may beprogrammed to trigger a notification to place the Ophthalmic Lens 403into the programming apparatus 450 for an upload. In some embodiments,the programming device 454 may further comprise executable software thatmay adjust the programming based on the uploaded data from theOphthalmic Lens 403.

As an illustrative example, an Ophthalmic Lens 403 may comprise amechanism for administering light therapy based on a programmedschedule. A doctor may initially set general programming parametersbased on the severity of the patient's condition. The doctor may alsoinclude a series of schedule factors that may warrant an adjustment inthe light schedule. Such factors may include, for example, exposure toambient light, activity levels, sleep cycles, and serotonin levels.After a specified amount of time, such as one week, the user may placethe used Ophthalmic Lens 403 back into the programming apparatus 450,which may then upload the factor data gathered throughout the week.Based on the newly uploaded data, the programming device 454 may adjustthe light therapy schedule. Such an embodiment may allow for continualoptimization without requiring constant doctor visits.

The programming apparatus 450 may include an independent power source,such as a battery, or may require an external power supply, such as byconnecting the programming apparatus 450 to a wall outlet or to acomputer. For example, a universal serial bus (USB) connector may allowa computer to charge the programming apparatus 450, upload data from theprogramming apparatus 450, and download the programming parameters tothe programming device 454. Some such embodiments may not require anoverlay for programming purposes.

Proceeding to FIG. 5, an embodiment of a programmable Ophthalmic Lensbase 531, a programming overlay 501, and a programming apparatus 520 areillustrated. In some embodiments, a programming overlay 501 may beprogrammed through use of a programming apparatus 520, and theprogramming overlay 501 may be combined with an Ophthalmic Lens 531 withan unprogrammed Media Insert 534.

A programming overlay 501 may be stored and processed while sealedwithin a container 500, similar to that described with FIGS. 3 and 4.The container 500 may include an alignment feature 502 that maycomplement an alignment feature 522 in the programming apparatus 520. Insome embodiments, the container 500 may include the SKU barcode, notshown, for example, by printing on the plastic portion 503.

In some embodiments, the container that may include the Ophthalmic Lensbase 531 and programmable Media Insert 534 may include the SKU barcode532 on the plastic portion 533. A scanning portion 524 of theprogramming apparatus 524 may scan either or both containers 500, 530.Scanning the SKU barcode 532 on one or both the containers 500, 530 mayprovide confirmation that the correct overlay 501 is being programmed.The SKU barcode 532 may also direct the programming apparatus 520 topull the programming parameters from a database.

As described with FIG. 4, the container 503 may be inserted or placedwithin the programming apparatus 520. A programming portion 521 maytransmit the programming parameters to the programming overlay 501, forexample, through logical communication with the processor or receivingportion.

In some embodiments, the container 500 with the programming overlay 501may be inserted or placed in the programming apparatus 520. Theprogramming apparatus 520 may include a programming portion 521 that maywirelessly transmit the programming parameters to the programmingoverlay 501. The programmed programming overlay 540 may be placed overthe Ophthalmic Lens base and programmable Media Insert assembly 560.

The placement may complete the formation of the programmed OphthalmicLens 570. In some embodiments, the placement may occur prior to placingthe Ophthalmic Lens base and programmable Media Insert assembly 560 onthe eye. In others, the programming overlay 530 may be placed over theassembly 560 when the assembly 560 is located on the eye.

In some embodiments, the Ophthalmic Lens base 531 and programmable MediaInsert 534 may be manufactured based on the programming parameters. Forexample, a programmable Ophthalmic Lens line may be capable ofmonitoring a wide range of tear fluid constituents, but a singleOphthalmic Lens 570 may be limited to three constituents. In some suchembodiments, the programming parameters may include selecting the threeconstituents. Accordingly, the Media Insert 534 may be assembled tospecifically include reactants to those three constituents.

Alternatively, programming parameter options may be based on the coreproperties of one or both the Ophthalmic Lens base 531 and theprogrammable Media Insert 534. For example, where an Ophthalmic Lensline includes a variable optic portion, the Media Inserts may beuniversal, and the Ophthalmic Lens bases may be offered in a limitedrange of static optic powers. In such embodiments, customizedmanufacturing may not be practical or offered.

Proceeding to FIG. 6, an alternate example of a process flow forassigning a SKU and programming an Ophthalmic Lens is illustrated. Insome embodiments, an unprogrammed Media Insert 621 may be manufacturedat 620 based on the programming parameters input at 600. At 610, a SKUand SKU barcode 611 may be generated based on the programmingparameters. At 620, the unprogrammed Media Insert 621 may be assembled.An Ophthalmic Lens 631 with an unprogrammed Media Insert 621 may beassembled at 630 and included within a container 641 at 640. Thecontainer 641 may include an alignment feature 642 and the SKU barcode611 associated with the programming parameters.

In some embodiments, the SKU 611 may be included on the container 641,such as, for example, where the Media Insert 621 is programmed whilestill sealed in the container 641. In some embodiments, the SKU 611 maybe included on one or both of the Ophthalmic Lens 630 and the MediaInsert 621, which may allow for programming after the Ophthalmic Lens630 is removed from the sealed container 641.

In some embodiments, at 650, the Ophthalmic Lens 630 may be placed in aprogramming apparatus 655, for example, while still sealed within thecontainer 641. In such aspects, an alignment feature 642 on thecontainer 641 may interface with a complementary alignment feature 652in a fitted cavity 654 within the programming apparatus 655, which mayorient and secure the position of the Ophthalmic Lens 630 relative tothe programming portion 653. A scanning portion 651 may scan thecontainer 641 or the Ophthalmic Lens 630 for the associated SKU 611. Aprogramming portion 653 may wirelessly program the Media Insert 621based on that SKU 611.

Such an embodiment may be significant where the customization mayrequire that the Media Insert 621 comprise specific components and wherethe programming may occur separately from the manufacturing process.Separating the programming of the Ophthalmic Lens 631 with the MediaInsert 621 from the manufacturing process may allow for a wider range ofprogramming options. As described with FIG. 3, a doctor, user, or anyonewith access to the programming apparatus or SKU settings may set theprogramming parameters.

In some embodiments, the programming parameters may be adjusted afterthe manufacturing process. Such an embodiment may allow a user to ordermultiple Ophthalmic Lenses with unprogrammed Media Inserts withoutcommitting to a single set of programming parameters. This may beparticularly preferable where the programming parameters may be or mayneed to be altered frequently.

For example, where a unique compound reacts with a constituent in thetear fluid, the reactants may be included during the manufacturingprocess, but the specific levels that may trigger a notification may betailored through use of a programming apparatus. Similarly, where theprogramming parameters may be altered based on data collected by theMedia Insert, a subsequently programmed Media Insert may requireadjusted programming parameters.

Another example may include a cosmetic functionality where a user mayselect an embedded, static design and a limited number of colors. Insome such embodiments, the same base design and colors may permit theuser to choose a variety of permutations, each capable of providing adistinct appearance.

Processes

Proceeding to FIG. 7, an exemplary flowchart of method steps formanufacturing an energizable Ophthalmic Lens with a programmable MediaInsert is illustrated. At 705, programming parameters may be uploadedinto the manufacturing system, and at 710, a stock-keeping unit may begenerated to uniquely identify the programming parameters and thecorresponding energized Ophthalmic Lens.

In some embodiments, the manufacturing may be performed in separateprocesses or even separate facilities, and the step at 705 may berepeated for each process portion. In some such embodiments, thestock-keeping unit generated at 710 may be universal for each separatemanufacturing process. A universal SKU may provide an effective methodof ensuring the separately manufactured components are correctlyassembled. For example, each component may include the SKU on somescannable surface.

In some embodiments, at 715, a processor may be programmed according tothe programming parameters, wherein the processor may be included in aMedia Insert. Programming the processor before encapsulating theelectrical components within the Media Insert may not limit programmingto wireless communication with the processor. Such an embodiment may notbe preferable where the programming parameters are likely to change foran individual patient or where reprogramming an Ophthalmic Lens may benecessary.

At 720, the Media Insert may be assembled. In some embodiments, theMedia Insert may comprise the processor electrically connected byconductive traces to a power source capable of providing power to anenergization element, wherein the energization element may providefunctionality to the energized Ophthalmic Lens. In embodiments wherewireless communication may be significant, the Media Insert may furthercomprise one or more of a wireless transmitter, a wireless receiver, ora wireless sensor.

In some embodiments, the components within the Media Insert may becustomizable, such as, for example, where the Media Insert may monitor alimited number of tear fluid constituents. The same Media Insert may becapable of monitoring temperature and pH within the ocular environment.In such embodiments, the assembly step at 720 may include selecting thecustomizable components based on the programming parameters. Forexample, specific reactants or binders may be indicative of aconcentration of the monitored constituents.

At 725, the Media Insert may be assembled into an Ophthalmic Lens. Insome embodiments, the Ophthalmic Lens may comprise a polymerizedReactive Monomer Mixture. In some embodiments, particularly where theMedia Insert may be wirelessly programmed, the assembly with theOphthalmic Lens may not impede or prevent wireless communication.Accordingly, where the polymerized RMM may inhibit wirelesscommunication, the Media Insert may not be fully encapsulated within theOphthalmic Lens. The assembly steps at 720 or 725 may include printingor embedding the SKU barcode on a surface of the Media Insert of thesoft lens portion, which may be preferable where the Ophthalmic Lens maybe wireless programmed.

The Ophthalmic Lens may be formed through a variety of methods,including, for example, injection molding or freeform techniques.Injection molding techniques may utilize a front curve mold piece and aback curve mold piece, wherein the Media Insert and a Reactive MonomerMixture may be placed between the two mold pieces. The RMM may bepolymerized between the mold pieces to encapsulate or at least securethe Media Insert to the Ophthalmic Lens.

Alternatively, freeform techniques may utilize actinic radiation tocontrol polymerization on a voxel by voxel basis over a forming surface;wherein the actinic radiation may comprise a wavelength at leastpartially absorbed by the photoabsorptive component. In suchembodiments, the RMM may comprise a photoabsorptive material. In someaspects, the Media Insert may be placed in or in contact with the RMMprior to polymerization, wherein exposure to the actinic radiationsecures the position of the Media Insert in the Ophthalmic Lens.Alternatively, the Media Insert may be placed in contact withpolymerized RMM, and the position may be secured by additionalcomponents, including, for example, alignment features or adhesives.

In some embodiments, at 730, the energizable Ophthalmic Lens may bepackaged. The packaging may be particularly significant where theenergizable Ophthalmic Lens may be programmed through a sealedcontainer. A typical packaging for an Ophthalmic Lens may include ablister embodiment, wherein the blister comprises a plastic base and asealing layer. The plastic base may include a reservoir portion capableof containing the Ophthalmic Lens in an aqueous solution. The assignedSKU barcode may be printed or embedded on a visible or scannable portionof the sealed container. The packaging at 730 may include a labelingprocess wherein some or all of the programming parameters are listed onthe sealed container, for example.

Proceeding to FIG. 8, an exemplary flowchart of method steps forprogramming an energizable Ophthalmic Lens with a programmable MediaInsert is illustrated. In such embodiments, the programming process mayoccur after the Media Insert is included in the Ophthalmic Lens. Theprogramming may be directly transmitted to the Media Insert orindirectly through use of an overlay capable of programming the MediaInsert. In some embodiments, the steps may be performed by a programmingapparatus, which are illustrated for exemplary purposes. Otherembodiments that may include manual performance of at least some of thesteps are also within the scope of the inventive art.

At 805, the programming parameters may be received. In some embodiments,the programming parameters may be directly input to the programmingapparatus or may be received from an external device, such as through aninternet connection or through use of a universal serial bus. In somesuch embodiments, the programming apparatus may include a database ofprogramming parameters organized, for example, by stock-keeping units.

In some embodiments, the programming apparatus may be capable ofaccessing and dispensing unprogrammed Ophthalmic Lenses or overlays. Insuch embodiments, at 810, the programming apparatus may select thespecified unprogrammed Ophthalmic Lens or overlay, and at 815, theprogramming apparatus may place the Lens or overlay in proximity to theprogramming portion of the programming apparatus. In other embodiments,at 815, the programming apparatus may receive the unprogrammedOphthalmic Lens or overlay, such as, for example, where a user orexternal mechanism may place the Lens or overlay.

In some embodiments, a stock-keeping unit (SKU) may be generated foreach set of programming parameters. In some such embodiments, at 820, aSKU barcode may be scanned. The SKU barcode may be included on one ormore of the overlay, the Ophthalmic Lens base, the Media Insert, or thecontainer. Scanning the SKU barcode may provide a method of verifyingthe correct unprogrammed Ophthalmic Lens or overlay has been placed inthe programming apparatus. Alternatively, the programming apparatus mayaccess a database of programming parameters and may pull the parametersbased on the SKU. In such embodiments, the step at 820 may prompt thestep at 805, or the steps at 805 and 820 may occur concurrently.

At 825, the programming apparatus may wirelessly transmit theprogramming parameters to the overlay or to the Media Insert. In someaspects, the programming apparatus may be manually prompted to transmit.In other aspects, the programming apparatus may automatically transmitonce the overlay or Ophthalmic Lens is placed in a predefined positionin or relative to the programming apparatus.

In some embodiments, at 830, the programming apparatus may release theprogrammed overlay or Ophthalmic Lens. Alternatively, where theOphthalmic Lens or overlay may not be secured in the programmingapparatus, the release step at 830 may not be necessary. In embodimentswith an overlay, at 835, the programming apparatus may optionallyassemble the Ophthalmic Lens and place the programmed overlay inproximity to the Ophthalmic Lens base with the Media Insert. In otherembodiments, the overlay may be manually combined with the OphthalmicLens base, such as by a user or an ophthalmologist.

Some aspects of programming may allow for adjustments to the programmingparameters based on data collected by a programmed Media Insert, whilethe Ophthalmic Lens is located on the eye. In such embodiments, at 840,the programming apparatus may receive the Ophthalmic Lens after use, andat 845, the programming apparatus may wirelessly receive or upload datacollected by the Media Insert. Similar to the step at 815, theOphthalmic Lens may not be placed within the programming apparatus. Insome such embodiments, at 845, the programming apparatus may be placedin proximity to the Ophthalmic Lens, or the Ophthalmic Lens may beplaced in proximity to the programming apparatus.

At 850, the data may be transmitted to an external device, such as acomputer, where the data may be reviewed, such as by an ophthalmologist.In some embodiments, at 855, the original programming parametersreceived at step 805 may be adjusted based on the received data. Forexample, the programming apparatus may comprise executable softwarecapable of processing the received data relative to programmingparameters. In such embodiments, the programming process may be repeatedwith the same or a second Ophthalmic Lens based on the adjustedprogramming parameters.

Materials for Insert Based Ophthalmic Lenses

In some embodiments, a lens type can be a lens that includes asilicone-containing component. A “silicone-containing component” is onethat contains at least one [—Si—O—] unit in a monomer, macromer orprepolymer. Preferably, the total Si and attached O are present in thesilicone-containing component in an amount greater than about 20 weightpercent, and more preferably greater than 30 weight percent of the totalmolecular weight of the silicone-containing component. Usefulsilicone-containing components preferably comprise polymerizablefunctional groups such as acrylate, methacrylate, acrylamide,methacrylamide, vinyl, N-vinyl lactam, N-vinylamide, and styrylfunctional groups.

In some embodiments, the Ophthalmic Lens skirt, which sometimes may becalled an insert encapsulating layer, that surrounds the insert may becomprised of standard hydrogel lens formulations. Exemplary materialswith characteristics that may provide an acceptable match to numerousinsert materials may include the Narafilcon family; including NarafilconA and Narafilcon B. Alternatively, the Etafilcon family; includingEtafilcon A may represent good exemplary material choices. A moretechnically inclusive discussion follows on the nature of materialsconsistent with the art herein; but it may be clear that any materialwhich may form an acceptable enclosure or partial enclosure of thesealed and encapsulated inserts are consistent and included.

Suitable silicone containing components include compounds of Formula I

where:

R¹ is independently selected from monovalent reactive groups, monovalentalkyl groups, or monovalent aryl groups, any of the foregoing which mayfurther comprise functionality selected from hydroxy, amino, oxa,carboxy, alkyl carboxy, alkoxy, amido, carbamate, carbonate, halogen orcombinations thereof; and monovalent siloxane chains comprising 1-100Si—O repeat units which may further comprise functionality selected fromalkyl, hydroxy, amino, oxa, carboxy, alkyl carboxy, alkoxy, amido,carbamate, halogen or combinations thereof;

where b=0 to 500, where it is understood that when b is other than 0, bis a distribution having a mode equal to a stated value;

wherein at least one R¹ comprises a monovalent reactive group, and insome embodiments between one and 3R¹ comprise monovalent reactivegroups.

As used herein “monovalent reactive groups” are groups that can undergofree radical and/or cationic polymerization. Non-limiting examples offree radical reactive groups include (meth)acrylates, styryls, vinyls,vinyl ethers, C₁₋₆alkyl(meth)acrylates, (meth)acrylamides,C₁₋₆alkyl(meth)acrylamides, N-vinyllactams, N-vinylamides,C₂₋₁₂alkenyls, C₂₋₁₂alkenylphenyls, C₂₋₁₂alkenylnaphthyls,C₂₋₆alkenylphenylC₁₋₆alkyls, O-vinylcarbamates and O-vinylcarbonates.Non-limiting examples of cationic reactive groups include vinyl ethersor epoxide groups and mixtures thereof. In one embodiment the freeradical reactive groups comprises (meth)acrylate, acryloxy,(meth)acrylamide, and mixtures thereof.

Suitable monovalent alkyl and aryl groups include unsubstitutedmonovalent C₁ to C₁₆alkyl groups, C₆-C₁₄ aryl groups, such assubstituted and unsubstituted methyl, ethyl, propyl, butyl,2-hydroxypropyl, propoxypropyl, polyethyleneoxypropyl, combinationsthereof and the like.

In one embodiment b is zero, one R¹ is a monovalent reactive group, andat least 3R¹ are selected from monovalent alkyl groups having one to 16carbon atoms, and in another embodiment from monovalent alkyl groupshaving one to 6 carbon atoms. Non-limiting examples of siliconecomponents of this embodiment include2-methyl-,2-hydroxy-3-[3-[1,3,3,3-tetramethyl-1-[(trimethylsilyl)oxy]disiloxanyl]propoxy]propylester (“SiGMA”),2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane,3-methacryloxypropyltris(trimethylsiloxy)silane (“TRIS”),3-methacryloxypropylbis(trimethylsiloxy)methylsilane and3-methacryloxypropylpentamethyl disiloxane.

In another embodiment, b is 2 to 20, 3 to 15 or in some embodiments 3 to10; at least one terminal R¹ comprises a monovalent reactive group andthe remaining R¹ are selected from monovalent alkyl groups having 1 to16 carbon atoms, and in another embodiment from monovalent alkyl groupshaving 1 to 6 carbon atoms. In yet another embodiment, b is 3 to 15, oneterminal R¹ comprises a monovalent reactive group, the other terminal R¹comprises a monovalent alkyl group having 1 to 6 carbon atoms and theremaining R¹ comprise monovalent alkyl group having 1 to 3 carbon atoms.Non-limiting examples of silicone components of this embodiment include(mono-(2-hydroxy-3-methacryloxypropyl)-propyl ether terminatedpolydimethylsiloxane (400-1000 MW)) (“OH-mPDMS”), monomethacryloxypropylterminated mono-n-butyl terminated polydimethylsiloxanes (800-1000 MW),(“mPDMS”).

In another embodiment b is 5 to 400 or from 10 to 300, both terminal R¹comprise monovalent reactive groups and the remaining R¹ areindependently selected from monovalent alkyl groups having 1 to 18carbon atoms which may have ether linkages between carbon atoms and mayfurther comprise halogen.

In one embodiment, where a silicone hydrogel lens is desired, the lensof the present invention will be made from a Reactive Mixture comprisingat least about 20 and preferably between about 20 and 70% wt siliconecontaining components based on total weight of reactive monomercomponents from which the polymer is made.

In another embodiment, one to four R¹ comprises a vinyl carbonate orcarbamate of the formula:

wherein: Y denotes O—, S— or NH—;

R denotes, hydrogen or methyl; d is 1, 2, 3 or 4; and q is 0 or 1.

The silicone-containing vinyl carbonate or vinyl carbamate monomersspecifically include:1,3-bis[4-(vinyloxycarbonyloxy)but-1-yl]tetramethyl-disiloxane;3-(vinyloxycarbonylthio)propyl-[tris(trimethylsiloxy)silane];3-[tris(trimethylsiloxy)silyl]propyl allyl carbamate;3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate;trimethylsilylethyl vinyl carbonate; trimethylsilylmethyl vinylcarbonate, and

Where biomedical devices with modulus below about 200 are desired, onlyone R¹ shall comprise a monovalent reactive group and no more than twoof the remaining R¹ groups will comprise monovalent siloxane groups.

Another class of silicone-containing components includes polyurethanemacromers of the following formulae:(*D*A*D*G)_(a)*D*D*E¹;E(*D*G*D*A)_(a)*D*G*D*E¹ or;E(*D*A*D*G)_(a)*D*A*D*E¹  Formulae IV-VIwherein:

D denotes an alkyl diradical, an alkyl cycloalkyl diradical, acycloalkyl diradical, an aryl diradical or an alkylaryl diradical having6 to 30 carbon atoms,

G denotes an alkyl diradical, a cycloalkyl diradical, an alkylcycloalkyl diradical, an aryl diradical or an alkylaryl diradical having1 to 40 carbon atoms and which may contain ether, thio or amine linkagesin the main chain;

denotes a urethane or ureido linkage;

_(α)is at least 1;

A denotes a divalent polymeric radical of formula:

R¹¹ independently denotes an alkyl or fluoro-substituted alkyl grouphaving 1 to 10 carbon atoms which may contain ether linkages betweencarbon atoms; y is at least 1; and p provides a moiety weight of 400 to10,000; each of E and E¹ independently denotes a polymerizableunsaturated organic radical represented by formula:

wherein: R¹² is hydrogen or methyl; R¹³ is hydrogen, an alkyl radicalhaving 1 to 6 carbon atoms, or a —CO—Y—R¹⁵ radical wherein Y is —O—,Y—S—or —NH—; R¹⁴ is a divalent radical having 1 to 12 carbon atoms; Xdenotes —CO— or —OCO—; Z denotes —O— or —NH—; Ar denotes an aromaticradical having 6 to 30 carbon atoms; w is 0 to 6; x is 0 or 1; y is 0 or1; and z is 0 or 1.

A preferred silicone-containing component is a polyurethane macromerrepresented by the following formula:

wherein R¹⁶ is a diradical of a diisocyanate after removal of theisocyanate group, such as the diradical of isophorone diisocyanate.Another suitable silicone containing macromer is compound of formula X(in which x+y is a number in the range of 10 to 30) formed by thereaction of fluoroether, hydroxy-terminated polydimethylsiloxane,isophorone diisocyanate and isocyanatoethylmethacrylate.

Other silicone containing components suitable for use in this inventioninclude macromers containing polysiloxane, polyalkylene ether,diisocyanate, polyfluorinated hydrocarbon, polyfluorinated ether andpolysaccharide groups; polysiloxanes with a polar fluorinated graft orside group having a hydrogen atom attached to a terminaldifluoro-substituted carbon atom; hydrophilic siloxanyl methacrylatescontaining ether and siloxanyl linkanges and crosslinkable monomerscontaining polyether and polysiloxanyl groups. Any of the foregoingpolysiloxanes can also be used as the silicone-containing component inthis invention.

Conclusion

The present invention, as described above and as further defined by theclaims below, provides an Ophthalmic Lens device with a programmableMedia Insert. In some embodiments, a Media Insert may be programmable toallow for further customization of the energized Ophthalmic Lens. Theprogramming may occur after the electrical components have beenencapsulated in the programmable Media Insert.

In some embodiments, the Media Insert may be programmed prior to orduring the manufacturing process. Alternatively, the Media Insert may beprogrammable after manufacturing process, such as, for example, throughuse of a wireless programming apparatus or device. In some suchembodiments, the programming device may comprise an overlay, wherein theoverlay may program the Media Insert when placed in proximity to theMedia Insert.

The invention claimed is:
 1. An ophthalmic lens comprising: aprogrammable media insert containing a power source, a first processor,an energizable element and a plurality of conductive traces, wherein theprogrammable media insert is capable of providing a first functionalityto the ophthalmic lens, wherein a set of programming parameters iscapable of customizing the first functionality; and a soft lens base,wherein the soft lens base is in contact with at least a portion of theprogrammable media insert.
 2. The ophthalmic lens of claim 1, wherein:the first processor is in electrical communication with the powersource, the first processor comprises a first executable softwarecapable of controlling the energizable element based on the set ofprogramming parameters, the conductive traces are capable of allowingelectrical communication between the first processor and the powersource, the energizable element is in electrical communication with thefirst processor and the power source, and the energizable element iscapable of providing the first functionality to the ophthalmic lens. 3.The ophthalmic lens of claim 2, wherein the programmable media insertfurther comprises: a first receiver capable of wirelessly receiving theset of programming parameters, wherein the first receiver is inelectrical communication with the first processor.
 4. The ophthalmiclens of claim 3, further comprising: a programming overlay capable ofprogramming the programmable media insert, wherein the programmingoverlay is capable of securely fitting over one or both of the soft lensbase and the programmable media insert.
 5. The ophthalmic lens of claim4, further comprising a stock-keeping unit code capable of associatingthe set of programming parameters with the ophthalmic lens, wherein thestock-keeping unit code is incorporated on a surface of the programmingoverlay.
 6. The ophthalmic lens of claim 4, wherein the placing of theprogramming overlay is capable of occurring when the soft lens base andprogrammable media insert are located on an eye.
 7. The ophthalmic lensof claim 4, wherein the placing of the programming overlay is capable ofoccurring prior to a placement of the soft lens base and programmablemedia insert on an eye.
 8. The ophthalmic lens of claim 4, wherein theprogramming overlay comprises: a second receiver capable of wirelesslyreceiving programming parameter data; a first transmitter capable ofwirelessly transmitting the set of programming parameters to theprogrammable media insert when the first transmitter is in proximity tothe programmable media insert; and a second processor in logicalcommunication with the second receiver and the first transmitter,wherein the second processor is capable of storing the set ofprogramming parameter.
 9. The ophthalmic lens of claim 8, wherein theprogrammable media insert further comprises: a monitoring portion inelectrical communication with the first processor, wherein themonitoring portion is capable of collecting predefined data while theophthalmic lens is located on an eye, and wherein the first processor iscapable of storing the predefined data; and a second transmitter,wherein the second transmitter is capable of wirelessly transmitting thepredefined data to a third receiver.
 10. The ophthalmic lens of claim 9,wherein: the programming overlay further comprises the third receiver;the third receiver is in logical communication with the second processorthe second processor comprises a second executable software; the secondexecutable software is capable of adjusting the set of programmingparameters based on the predefined data; and the first transmitter iscapable of wirelessly transmitting the adjusted set of programmingparameters to the programmable media insert.
 11. The ophthalmic lens ofclaim 8, wherein: the programming overlay further comprises a firstalignment feature; the programmable media insert comprises a secondalignment feature; and the first alignment feature is capable ofaligning with the second alignment feature.
 12. The ophthalmic lens ofclaim 11, wherein the aligning comprises a magnetic attraction betweenthe first alignment feature and the second alignment feature.
 13. Theophthalmic lens of claim 11, wherein the aligning is capable oforienting the first transmitter in proximity to the first receiver. 14.The ophthalmic lens of claim 11, wherein the aligning is capable ofsecuring the programming overlay to one or both the soft lens base andthe programmable media insert.
 15. The ophthalmic lens of claim 3,wherein the programmable media insert further comprises: a monitoringportion in electrical communication with the first processor, whereinthe monitoring portion is capable of collecting predefined data whilethe ophthalmic lens is located on an eye, and wherein the firstprocessor is capable of storing the predefined data; and a secondtransmitter, wherein the second transmitter is capable of wirelesslytransmitting the predefined data to a device external to the ophthalmiclens.
 16. The ophthalmic lens of claim 1, wherein the soft lens base iscapable of providing a second functionality to the ophthalmic lens. 17.The ophthalmic lens of claim 16, wherein the second functionalitycomprises a static vision-correction.
 18. The ophthalmic lens of claim1, further comprising a stock-keeping unit code capable of associatingthe set of programming parameters with the ophthalmic lens.
 19. Theophthalmic lens of claim 18, wherein the stock-keeping unit code isincorporated on a surface of the programmable media insert.
 20. Theophthalmic lens of claim 18, wherein the stock-keeping unit code isincorporated on a surface of the soft lens base.
 21. The ophthalmic lensof claim 1, wherein the programmable media insert further comprises: aliquid lens or liquid crystal portion in an optic zone of the ophthalmiclens.
 22. The ophthalmic lens of claim 1, wherein the programmable mediainsert is annular.
 23. The ophthalmic lens of claim 1, wherein theprogrammable media insert has an optic zone void of material.
 24. Theophthalmic lens of claim 1, wherein the programmable media insertfurther comprises: a substrate, wherein the power source, the firstprocessor, the energizable element and the conductive traces areattached to the substrate.